Effectiveness of RPT With Elastic Band in Tx of Sarcopenia in LTCFs

Official title

The Clinical Effectiveness of Progressive Resistance Training With Elastic Band in Postponing and Preventing Sarcopenia Among Older Adults in Rural Long-Term Care Facilities

Overview

The goal of this clinical trial is to evaluate the effectiveness of progressive resistance training using elastic bands in treating and delaying the progression of sarcopenia among older adults in long-term care facilities. Sarcopenia, characterized by a progressive decline in muscle mass and strength, affects more than 20% of individuals aged over 65 in Taiwan and is a significant risk factor for impaired daily functioning, falls, and increased mortality in older adults. While resistance or aerobic exercises are known to improve muscle strength and function in the elderly, such interventions are challenging to implement long-term in rural care facilities due to limited resources. The study aims to determine: Whether elastic band progressive resistance training can achieve clinical benefits in treating and delaying sarcopenia with minimal rehabilitation personnel. Whether this training model can be adapted to rural care facilities and other resource-limited settings, aligning with the goals of Taiwan's Long-Term Care 2.0 program. Participants will engage in a 12-week program, involving twice-weekly, 30-minute sessions of upper and lower limb resistance training using elastic bands. The training incorporates major muscle groups and proprioceptive neuromuscular facilitation (PNF) techniques. Primary outcomes: Skeletal muscle mass index of the limbs Dominant hand grip strength Walking speed SARC-F questionnaire scores Secondary outcomes: Maximal voluntary isometric contraction (MVIC) of the dominant hand Muscle thickness assessed via ultrasound Functional activities of the dominant upper limb Calf circumference Quality of life indicators The study will be conducted in long-term care facilities affiliated with or contracted by the Ministry of Health and Welfare Qishan Hospital. The findings aim to provide evidence for scalable, low-resource sarcopenia interventions suitable for rural and underserved populations.

Detailed description

Study Objectives Sarcopenia is a progressive condition characterized by the loss of muscle mass and decline in muscle function. The prevalence of sarcopenia in the elderly population aged over 65 years in Taiwan exceeds 20%. Sarcopenia is an independent risk factor for impaired daily functioning, falls, and increased mortality among older adults. Previous studies have demonstrated that resistance or aerobic exercise can improve muscle strength and functionality in the elderly. However, due to manpower constraints, such exercise programs are challenging to implement long-term in rural care facilities. Therefore, a simple and safe resistance training model that minimizes the risk of exercise-related injuries in older populations is needed.

Previous research has shown that progressive resistance training using elastic bands can effectively enhance muscle strength in older adults under safe conditions while reducing the risk of bone and joint injuries associated with traditional resistance training. However, the efficacy of elastic band training in delaying the progression of sarcopenia and determining the optimal exercise prescription for the elderly remain contentious.

This study aims to implement progressive resistance training using elastic bands for the upper and lower limbs of older adults in long-term care facilities to achieve the following expected outcomes:

Demonstrate that progressive resistance training using elastic bands can provide clinical benefits in treating and delaying sarcopenia with minimal rehabilitation personnel, while minimizing the risk of exercise-related injuries.

Apply the findings to rural daycare centers and other facilities with limited manpower resources, aligning with the goals of Taiwan's current Long-Term Care 2.0 program.

Study Methods This study will be conducted in long-term care facilities affiliated with or contracted by the Ministry of Health and Welfare Qishan Hospital, including nursing homes and daycare centers. Older adults with sufficient cognitive function to participate in rehabilitation exercises will undergo a 12-week intervention of progressive resistance training using elastic bands, performed twice per week. The training will target major muscle groups of the upper and lower limbs and incorporate proprioceptive neuromuscular facilitation (PNF) techniques. Each session will last 30 minutes.

The differences in primary and secondary outcomes will be compared before and after the intervention.

Primary outcomes include diagnostic criteria for sarcopenia: appendicular skeletal muscle mass index, dominant hand grip strength, walking speed, and SARC-F questionnaire scores.

Secondary outcomes include maximal voluntary isometric contraction (MVIC) of the dominant hand, muscle thickness assessed via ultrasound, functional activities of the dominant upper limb, calf circumference, and quality of life indicators.

Interventions

• Device elastic band
  Participants in the experimental group will receive standard care plus progressive resistance training with elastic band (PRT-EB). The PRT-EB is planned to last for 12 weeks, with at least two sessions per week and a minimum interval of one day between sessions. Before each training session, participants will perform a 5-15-minute warm-up exercise led by the research staff. This will be followed by a 30-minute main rehabilitation exercise program and a subsequent 5-15-minute cool-down session.

Primary outcome measures

• Appendicular Skeletal Muscle Mass Index [Time frame: From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.]
• Handgrip strength of dominant hand [Time frame: From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.]
• Gait speed [Time frame: From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.]
• SARC-F questionnaire [Time frame: From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.]

Secondary outcome measures (8)

• maximal voluntary isometric contraction of biceps brachii/ triceps brachii/ quadriceps muscle [Time frame: From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.]
• Sonographic thickness of biceps brachii muscle [Time frame: From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.]
• Sonographic thickness of quadriceps muscle [Time frame: From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.]
• Sonographic thickness of gastrocnemius muscle [Time frame: From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.]
• hand dexterity [Time frame: From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.]
• Calf Circumference [Time frame: From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.]
• EQ-5D questionnaire [Time frame: From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.]
• Mini Nutritional Assessment [Time frame: From enrollment (baseline) to the mid-term (at the 6th week) and the end (at the 12th week) of the intervention.]

Eligibility criteria

Inclusion criteria

• Older adults aged 60 years or above who are either receiving daycare services at long-term care facilities affiliated with or contracted by this hospital, or residents living in the hospital-affiliated nursing home.
• Individuals with sufficient cognitive and physical capacity to participate in a progressive resistance training program incorporating elastic bands, with each session lasting at least 30 minutes. -

Exclusion criteria

• Inability to maintain a seated position for more than one hour.
• Presence of uncontrolled hypertension, recent infections, major cardiovascular diseases, or other contraindications to exercise training as defined by the American College of Sports Medicine (ACSM).
• Long-term bedridden individuals unable to participate in the progressive resistance training program incorporating elastic bands.
• Individuals with respiratory diseases requiring regular oxygen support in daily life.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Taiwan · 1 center

• CiShan hospital, MOHW — Kaohsiung City

Publications

• Inder JD, Carlson DJ, Dieberg G, McFarlane JR, Hess NC, Smart NA. Isometric exercise training for blood pressure management: a systematic review and meta-analysis to optimize benefit. Hypertens Res. 2016 Feb;39(2):88-94. doi: 10.1038/hr.2015.111. Epub 2015 Oct 15. PMID 26467494
• Baek SH, Sung JH, Park JW, Son MH, Lee JH, Kim BJ. Usefulness of muscle ultrasound in appendicular skeletal muscle mass estimation for sarcopenia assessment. PLoS One. 2023 Jan 17;18(1):e0280202. doi: 10.1371/journal.pone.0280202. eCollection 2023. PMID 36649288
• Chen KM, Li CH, Huang HT, Cheng YY. Feasible modalities and long-term effects of elastic band exercises in nursing home older adults in wheelchairs: A cluster randomized controlled trial. Int J Nurs Stud. 2016 Mar;55:4-14. doi: 10.1016/j.ijnurstu.2015.11.004. Epub 2015 Nov 28. PMID 26655368
• Fragala MS, Cadore EL, Dorgo S, Izquierdo M, Kraemer WJ, Peterson MD, Ryan ED. Resistance Training for Older Adults: Position Statement From the National Strength and Conditioning Association. J Strength Cond Res. 2019 Aug;33(8):2019-2052. doi: 10.1519/JSC.0000000000003230. PMID 31343601
• Akehurst E, Scott D, Rodriguez JP, Gonzalez CA, Murphy J, McCarthy H, Dorgo S, Hayes A. Associations of sarcopenia components with physical activity and nutrition in Australian older adults performing exercise training. BMC Geriatr. 2021 Apr 26;21(1):276. doi: 10.1186/s12877-021-02212-y. PMID 33902464
• Vlietstra L, Hendrickx W, Waters DL. Exercise interventions in healthy older adults with sarcopenia: A systematic review and meta-analysis. Australas J Ageing. 2018 Sep;37(3):169-183. doi: 10.1111/ajag.12521. Epub 2018 Apr 11. PMID 29638028
• Chen GB, Lin CW, Huang HY, Wu YJ, Su HT, Sun SF, Tuan SH. Using Virtual Reality-Based Rehabilitation in Sarcopenic Older Adults in Rural Health Care Facilities-A Quasi-Experimental Study. J Aging Phys Act. 2021 Oct 1;29(5):866-877. doi: 10.1123/japa.2020-0222. Epub 2021 Feb 16. PMID 33596540
• Liu CJ, Latham NK. Progressive resistance strength training for improving physical function in older adults. Cochrane Database Syst Rev. 2009 Jul 8;2009(3):CD002759. doi: 10.1002/14651858.CD002759.pub2. PMID 19588334

Identifiers

NCT: NCT07513025 · CHIS11403

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗